PRIA, Government Policy, Made Personal

Summary

Explains the exact meanings of important words used in the chapter so people know who is covered, who can sue, and who is excluded. Biomaterials supplier is anyone who supplies a component or raw material used to make an implant, and it includes people who filed master files with the Secretary for device approval or who license others to make parts or raw materials. Claimant is a person who brings (or on whose behalf a suit is brought) a civil case for harm tied to an implant; it also includes a deceased implant recipient’s estate and parents or guardians for minors or incompetents. Claimant does not include health care providers when the implant is only incidental and the care is mainly judgment or skill, nor does it include manufacturers, sellers, or biomaterials suppliers, nor people alleging harm from silicone gel or the silicone envelope used in silicone-gel breast implants; that silicone exclusion is not a finding about silicone safety and may not be shown to a jury or used in court except to show this chapter applies. Component part is a manufactured piece of an implant, even if it has non-implant uses or only works when combined with other parts. Harm means injury, illness, disease, death, or any loss caused by those things, but not commercial loss or damage to the implant itself. Implant means a medical device meant to be placed in a body cavity for at least 30 days, or to touch internal tissue or fluids through a surgical opening for less than 30 days, and includes suture materials used in implant procedures. Manufacturer is anyone who makes or processes an implant and must register and list the device with the Secretary. Medical device means a device as defined by law and includes device parts of combination products. Raw material is a substance with general uses that can be used for things other than implants. Secretary means the Secretary of Health and Human Services. Seller is someone who, as a business, sells, distributes, leases, packages, labels, or otherwise puts an implant into commerce; it does not include sellers of real estate, health care providers when the implant sale or use is incidental and the care is mainly judgment or skill, or people who only act in a financial role.

Title 21, §1602

Food and Drugs, Source: USLM XML via OLRC

As used in this chapter:

(1)Biomaterials supplier

(A)In general

The term “biomaterials supplier” means an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant.

(B)Persons included

Such term includes any person who—

(i)has submitted master files to the Secretary for purposes of premarket approval of a medical device; or

(ii)licenses a biomaterials supplier to produce component parts or raw materials.

(2)Claimant

(A)In general

The term “claimant” means any person who brings a civil action, or on whose behalf a civil action is brought, arising from harm allegedly caused directly or indirectly by an implant, including a person other than the individual into whose body, or in contact with whose blood or tissue, the implant is placed, who claims to have suffered harm as a result of the implant.

(B)Action brought on behalf of an estate

With respect to an action brought on behalf of or through the estate of a deceased individual into whose body, or in contact with whose blood or tissue the implant was placed, such term includes the decedent that is the subject of the action.

(C)Action brought on behalf of a minor or incompetent

With respect to an action brought on behalf of or through a minor or incompetent, such term includes the parent or guardian of the minor or incompetent.

(D)Exclusions

Such term does not include—

(i)a provider of professional health care services in any case in which—

(I)the sale or use of an implant is incidental to such services; and

(II)the essence of the professional health care services provided is the furnishing of judgment, skill, or services;

(ii)a person acting in the capacity of a manufacturer, seller, or biomaterials supplier; or

(iii)a person alleging harm caused by either the silicone gel or the silicone envelope utilized in a breast implant containing silicone gel, except that—

(I)neither the exclusion provided by this clause nor any other provision of this chapter may be construed as a finding that silicone gel (or any other form of silicone) may or may not cause harm; and

(II)the existence of the exclusion under this clause may not—

(aa)be disclosed to a jury in any civil action or other proceeding; and

(bb)except as necessary to establish the applicability of this chapter, otherwise be presented in any civil action or other proceeding.

(3)Component part

(A)In general

The term “component part” means a manufactured piece of an implant.

(B)Certain components

Such term includes a manufactured piece of an implant that—

(i)has significant non-implant applications; and

(ii)alone, has no implant value or purpose, but when combined with other component parts and materials, constitutes an implant.

(4)Harm

(A)In general

The term “harm” means—

(i)any injury to or damage suffered by an individual;

(ii)any illness, disease, or death of that individual resulting from that injury or damage; and

(iii)any loss to that individual or any other individual resulting from that injury or damage.

(B)Exclusion

The term does not include any commercial loss or loss of or damage to an implant.

(5)Implant

The term “implant” means—

(A)a medical device that is intended by the manufacturer of the device—

(i)to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days; or

(ii)to remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days; and

(B)suture materials used in implant procedures.

(6)Manufacturer

The term “manufacturer” means any person who, with respect to an implant—

(A)is engaged in the manufacture, preparation, propagation, compounding, or processing (as defined in section 360(a)(1) of this title) of the implant; and

(B)is required—

(i)to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and

(ii)to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section.

(7)Medical device

The term “medical device” means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title.

(8)Raw material

The term “raw material” means a substance or product that—

(A)has a generic use; and

(B)may be used in an application other than an implant.

(9)Secretary

The term “Secretary” means the Secretary of Health and Human Services.

(10)Seller

(A)In general

The term “seller” means a person who, in the course of a business conducted for that purpose, sells, distributes, leases, packages, labels, or otherwise places an implant in the stream of commerce.

(B)Exclusions

The term does not include—

(i)a seller or lessor of real property;

(ii)a provider of professional health care services in any case in which—

(I)the sale or use of the implant is incidental to such services; and

(II)the essence of the professional health care services provided is the furnishing of judgment, skill, or services; or

(iii)any person who acts in only a financial capacity with respect to the sale of an implant.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

§1602 Definitions

Summary

Title 21, §1602

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Citations & Metadata